MoCRA and Hotel Toiletries: Who Does What
Hotel toiletries are cosmetics in the US, and MoCRA added facility registration, product listing, adverse event reporting and safety substantiation. The manufacturing facility registers itself; the responsible person named on the label, usually the brand owner or distributor, lists products and handles adverse events. The manufacturer supplies the documents that make this possible.
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), hotel shampoo, conditioner, shower gel, body lotion and cosmetic hand wash need a registered manufacturing facility, a product listing, a system for serious adverse event reports and evidence that each product is safe. The manufacturer registers its facility; the responsible person named on the label, usually the hotel brand owner or distributor, lists the products and reports adverse events.
MoCRA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and gave the FDA its biggest set of new cosmetics powers in decades. For hotel amenities the practical question is who does what between the hotel brand, the distributor and the manufacturer. This guide sets that out. For state rules, formats and shipping, see our US hotel amenities hub.
Why hotel toiletries are cosmetics
The FD&C Act defines cosmetics by intended use: products applied to the body for cleansing, beautifying or altering the appearance. Shampoo, conditioner, shower gel, 2-in-1, body lotion and a hand wash that simply cleans all fit that definition. The fact that a hotel gives them to guests free, rather than selling them on a shelf, does not take them outside the system, so treat in-room amenities as cosmetics in US commerce.
Claims can change the category. A hand wash labelled "antibacterial" or a shampoo that claims to treat dandruff is making drug claims, and over-the-counter (OTC) drug rules apply instead. Most hotel ranges stay cosmetic by keeping claims to cleansing, conditioning, moisturising and fragrance.
The responsible person
MoCRA places most duties on the "responsible person": the manufacturer, packer or distributor of a cosmetic whose name appears on the label. That definition follows the label, not the factory. If a bottle reads "Distributed by" an amenity supplier, that supplier is normally the responsible person. If it reads "Manufactured for" a hotel company, that company is.
For private-label hotel products this is usually the brand owner or distributor, not the contract manufacturer. Harrods Health makes products under the hotel's or distributor's name, so we do not act as the responsible person unless our name is on the label. Decide early whose name will appear, because it decides who carries the listing and reporting duties.
Who does what
| Duty | Who usually does it | What the manufacturer supplies |
|---|---|---|
| Facility registration | Owner or operator of the manufacturing facility | Registration and renewal of its own facility |
| Product listing | Responsible person (brand owner or distributor) | Ingredient lists and facility registration details |
| Serious adverse event reports | Responsible person | Batch records and support with investigations |
| Safety substantiation | Responsible person | Formula data, test reports, manufacturing documentation |
| Label contact details | Responsible person | Label printing to the approved artwork |
| Records | Responsible person and facility | Batch and production records |
Facility registration
Facilities that manufacture or process cosmetics for the US market must register with the FDA and keep the registration up to date. Facilities outside the United States must also name a US agent. Registration belongs to the facility, so a contract manufacturer registers its own plant, and a brand owner that only commissions products does not register someone else's factory.
Harrods Health's facility in India is US FDA registered. We provide the registration details your responsible person needs for product listings and supplier files.
Product listing
The responsible person lists each cosmetic product with the FDA, including the facility where it is made and its ingredients, and keeps listings updated when formulas change. For a hotel range, that means each product, and potentially each scent variant, has its own listing. Plan listings alongside artwork, because a change of fragrance or a new size may mean an update. We supply full ingredient lists for every formula and tell you in advance if a formula change is needed.
Serious adverse event reporting
If a guest suffers a serious adverse event linked to a product, such as a significant reaction needing medical treatment, the responsible person must report it to the FDA within a set deadline and keep records of adverse event reports. MoCRA also requires the label to carry a domestic address, phone number or electronic contact through which the responsible person can receive such reports.
For hotels this has an operational side. Front desk and housekeeping teams should know how to record a guest complaint about a reaction and pass it to whoever holds the responsible person role. The manufacturer supports the investigation with batch records and retained samples.
Safety substantiation
The responsible person must make sure there is adequate evidence that each product is safe under its intended use. In practice that file draws on the formula, ingredient safety data, test results and manufacturing information. We supply ingredient lists and manufacturing documentation, and formulas can be supplied as dermatologically tested with test reports on request. A qualified adviser can then assess whether the evidence is adequate for your product and claims.
What else MoCRA set in motion
MoCRA also directed the FDA to make rules in several areas that affect hotel amenities.
- Fragrance allergens. The FDA was directed to propose rules identifying fragrance allergens that must be declared on labels. Hotel ranges rely heavily on fragrance, so expect more detailed disclosure once the rules are final.
- Good manufacturing practice. The FDA was directed to set GMP regulations for cosmetic facilities. Our facility is already GMP-compliant and ISO certified; see quality and certifications.
- Records access. The FDA can request certain safety records in defined circumstances.
Some small businesses are exempt from certain requirements. Whether an exemption applies depends on the business and the products, so check with your adviser rather than assuming one.
Setting up a private-label hotel range
- Decide whose name goes on the label, and therefore who is the responsible person.
- Agree formulas, scents and formats, and collect ingredient lists and facility registration details from the manufacturer.
- Have artwork prepared with the correct identity, net quantity, ingredients, name and place of business, contact for adverse events and country of origin. Our custom packaging team prints it in-house.
- Complete product listings before the products are distributed.
- Set up an adverse event process covering hotel staff, the responsible person and the manufacturer.
Distributors supplying several hotel groups often hold the responsible person role across many listings. Independent hotels may prefer to buy from a distributor that already does. Either way, the manufacturer's job is to make the product consistently and supply documents promptly. Browse the formats in our hotel amenities collection, and if you also need Halal-certified products for some markets, see our Halal hotel toiletries guide.
MoCRA is still being implemented and FDA guidance continues to develop. Confirm current requirements with a regulatory consultant before you launch, and see our California page for state rules that sit on top of the federal ones.
Frequently asked questions
Is a contract manufacturer the responsible person under MoCRA?
Only if its name appears on the label as manufacturer, packer or distributor. For private-label hotel products the responsible person is usually the brand owner or distributor named on the label.
Who registers the factory with the FDA?
The owner or operator of the facility that manufactures or processes the product registers it. A facility outside the US must also name a US agent. Harrods Health's facility is US FDA registered.
Do free in-room amenities fall under MoCRA?
Treat them as within scope. Hotel toiletries are cosmetics distributed in US commerce, whether or not guests pay for them separately. Confirm any edge cases with a regulatory consultant.
Does each scent need its own product listing?
Listings cover the product and its ingredients, so formula differences such as fragrance matter. Your regulatory adviser will confirm how to structure listings for a range.
Planning a US range? Start with our US hotel amenities hub or read about private-label hotel toiletries.
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